EP4309673A3 - Formulations of guanylate cyclase c agonists and methods of use - Google Patents
Formulations of guanylate cyclase c agonists and methods of use Download PDFInfo
- Publication number
- EP4309673A3 EP4309673A3 EP23194256.6A EP23194256A EP4309673A3 EP 4309673 A3 EP4309673 A3 EP 4309673A3 EP 23194256 A EP23194256 A EP 23194256A EP 4309673 A3 EP4309673 A3 EP 4309673A3
- Authority
- EP
- European Patent Office
- Prior art keywords
- formulations
- methods
- guanylate cyclase
- agonists
- laxative
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000009472 formulation Methods 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 title abstract 3
- 102100034605 Atrial natriuretic peptide receptor 3 Human genes 0.000 title abstract 2
- 101000924488 Homo sapiens Atrial natriuretic peptide receptor 3 Proteins 0.000 title abstract 2
- 239000000556 agonist Substances 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 2
- ZOOGRGPOEVQQDX-UUOKFMHZSA-N 3',5'-cyclic GMP Chemical compound C([C@H]1O2)OP(O)(=O)O[C@H]1[C@@H](O)[C@@H]2N1C(N=C(NC2=O)N)=C2N=C1 ZOOGRGPOEVQQDX-UUOKFMHZSA-N 0.000 abstract 1
- 102000004861 Phosphoric Diester Hydrolases Human genes 0.000 abstract 1
- 108090001050 Phosphoric Diester Hydrolases Proteins 0.000 abstract 1
- 230000001419 dependent effect Effects 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 239000003112 inhibitor Substances 0.000 abstract 1
- 239000008141 laxative Substances 0.000 abstract 1
- 230000002475 laxative effect Effects 0.000 abstract 1
- 102000004196 processed proteins & peptides Human genes 0.000 abstract 1
- 108090000765 processed proteins & peptides Proteins 0.000 abstract 1
- 229940124597 therapeutic agent Drugs 0.000 abstract 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/10—Peptides having 12 to 20 amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/10—Laxatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/12—Antidiarrhoeals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K7/04—Linear peptides containing only normal peptide links
- C07K7/08—Linear peptides containing only normal peptide links having 12 to 20 amino acids
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K7/64—Cyclic peptides containing only normal peptide links
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Nutrition Science (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Enzymes And Modification Thereof (AREA)
Abstract
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/421,769 US9616097B2 (en) | 2010-09-15 | 2012-03-15 | Formulations of guanylate cyclase C agonists and methods of use |
EP13713280.9A EP2825188B1 (en) | 2012-03-15 | 2013-03-12 | Formulations of guanylate cyclase c agonists and methods of use |
EP20160418.8A EP3708179B1 (en) | 2012-03-15 | 2013-03-12 | Formulations of guanylate cyclase c agonists and methods of use |
PCT/US2013/030551 WO2013138352A1 (en) | 2012-03-15 | 2013-03-12 | Formulations of guanylate cyclase c agonists and methods of use |
Related Parent Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP20160418.8A Division EP3708179B1 (en) | 2012-03-15 | 2013-03-12 | Formulations of guanylate cyclase c agonists and methods of use |
EP13713280.9A Division EP2825188B1 (en) | 2012-03-15 | 2013-03-12 | Formulations of guanylate cyclase c agonists and methods of use |
Publications (2)
Publication Number | Publication Date |
---|---|
EP4309673A2 EP4309673A2 (en) | 2024-01-24 |
EP4309673A3 true EP4309673A3 (en) | 2024-03-20 |
Family
ID=48040418
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP23194256.6A Pending EP4309673A3 (en) | 2012-03-15 | 2013-03-12 | Formulations of guanylate cyclase c agonists and methods of use |
EP20160418.8A Active EP3708179B1 (en) | 2012-03-15 | 2013-03-12 | Formulations of guanylate cyclase c agonists and methods of use |
EP13713280.9A Active EP2825188B1 (en) | 2012-03-15 | 2013-03-12 | Formulations of guanylate cyclase c agonists and methods of use |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP20160418.8A Active EP3708179B1 (en) | 2012-03-15 | 2013-03-12 | Formulations of guanylate cyclase c agonists and methods of use |
EP13713280.9A Active EP2825188B1 (en) | 2012-03-15 | 2013-03-12 | Formulations of guanylate cyclase c agonists and methods of use |
Country Status (14)
Country | Link |
---|---|
US (1) | US9616097B2 (en) |
EP (3) | EP4309673A3 (en) |
JP (2) | JP6557138B2 (en) |
AU (1) | AU2013232306B2 (en) |
CA (1) | CA2867292A1 (en) |
EA (1) | EA038977B1 (en) |
ES (2) | ES2797628T3 (en) |
HK (1) | HK1204454A1 (en) |
HR (1) | HRP20240004T1 (en) |
PL (1) | PL3708179T3 (en) |
PT (1) | PT3708179T (en) |
RS (1) | RS65029B1 (en) |
SI (1) | SI3708179T1 (en) |
WO (1) | WO2013138352A1 (en) |
Families Citing this family (28)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2688161C (en) | 2007-06-04 | 2020-10-20 | Kunwar Shailubhai | Agonists of guanylate cyclase useful for the treatment of gastrointestinal disorders, inflammation, cancer and other disorders |
US8969514B2 (en) | 2007-06-04 | 2015-03-03 | Synergy Pharmaceuticals, Inc. | Agonists of guanylate cyclase useful for the treatment of hypercholesterolemia, atherosclerosis, coronary heart disease, gallstone, obesity and other cardiovascular diseases |
CA2726917C (en) | 2008-06-04 | 2018-06-26 | Synergy Pharmaceuticals Inc. | Agonists of guanylate cyclase useful for the treatment of gastrointestinal disorders, inflammation, cancer and other disorders |
JP2011528375A (en) | 2008-07-16 | 2011-11-17 | シナジー ファーマシューティカルズ インコーポレイテッド | Guanylate cyclase agonists useful for the treatment of gastrointestinal disorders, inflammation, cancer, and other disorders |
EP2373296B1 (en) | 2008-12-03 | 2016-08-03 | Synergy Pharmaceuticals Inc. | Formulations of guanylate cyclase c agonists and methods of use |
CA2810243C (en) * | 2010-09-15 | 2021-04-20 | Synergy Pharmaceuticals Inc. | Formulations of guanylate cyclase c agonists and methods of use |
US9616097B2 (en) | 2010-09-15 | 2017-04-11 | Synergy Pharmaceuticals, Inc. | Formulations of guanylate cyclase C agonists and methods of use |
WO2012118972A2 (en) * | 2011-03-01 | 2012-09-07 | Synegy Pharmaceuticals Inc. | Process of preparing guanylate cyclase c agonists |
AU2014218599C1 (en) * | 2013-02-25 | 2018-09-06 | Bausch Health Ireland Limited | Guanylate cyclase receptor agonists for use in colonic cleansing |
CA2905435A1 (en) | 2013-03-15 | 2014-09-25 | Synergy Pharmaceuticals Inc. | Compositions useful for the treatment of gastrointestinal disorders |
EP2970384A1 (en) | 2013-03-15 | 2016-01-20 | Synergy Pharmaceuticals Inc. | Agonists of guanylate cyclase and their uses |
DK2981269T3 (en) | 2013-04-04 | 2023-10-23 | Boehringer Ingelheim Vetmedica Gmbh | TREATMENT OF METABOLISM DISORDERS IN HORSES |
CN105764916B (en) | 2013-06-05 | 2021-05-18 | 博士医疗爱尔兰有限公司 | Ultra-pure agonists of guanylate cyclase C, methods of making and using the same |
WO2015054500A2 (en) * | 2013-10-09 | 2015-04-16 | Synergy Pharmaceuticals, Inc. | Agonists of guanylate cyclase useful for downregulation of pro-inflammatory cytokines |
MY176976A (en) * | 2013-10-10 | 2020-08-28 | Bausch Health Ireland Ltd | Agonists of guanylate cyclase useful for the treatment of opioid induced dysfunctions |
SI3862003T1 (en) | 2013-12-17 | 2024-02-29 | Boehringer Ingelheim Vetmedica Gmbh | An sglt-2 inhibitor for use in the treatment of a metabolic disorder in feline animals |
WO2015110402A1 (en) | 2014-01-23 | 2015-07-30 | Boehringer Ingelheim Vetmedica Gmbh | Treatment of metabolic disorders in canine animals |
ES2665180T3 (en) * | 2014-03-18 | 2018-04-24 | Apeptico Forschung Und Entwicklung Gmbh | Peptide drug in dry powder form |
PL3125882T3 (en) | 2014-04-01 | 2020-10-19 | Boehringer Ingelheim Vetmedica Gmbh | Treatment of metabolic disorders in equine animals |
WO2016028357A1 (en) * | 2014-08-19 | 2016-02-25 | Pascal Christian D | Treatment of ashy skin by a topical composition and methods of manufacture thereof |
CA2956257C (en) | 2014-09-25 | 2022-07-12 | Boehringer Ingelheim Vetmedica Gmbh | Combination treatment of sglt2 inhibitors and dopamine agonists for preventing metabolic disorders in equine animals |
US20160367623A1 (en) * | 2015-06-16 | 2016-12-22 | Synergy Pharmaceuticals, Inc. | Agonists of guanylate cyclase useful for the treatment of gastrointestinal disorders, inflammation, cancer and other disorders |
CN107995862B8 (en) * | 2015-08-27 | 2021-12-03 | 勃林格殷格翰维特梅迪卡有限公司 | Liquid pharmaceutical composition comprising SGLT-2 inhibitor |
EP3402804A1 (en) | 2016-01-11 | 2018-11-21 | Synergy Pharmaceuticals Inc. | Formulations and methods for treating ulcerative colitis |
CN107929718A (en) * | 2017-10-19 | 2018-04-20 | 南京星银药业集团有限公司 | 1 analogs of GLP and GC C receptor stimulating agent composition sustained-release preparations and preparation method thereof |
MX2021000312A (en) * | 2018-07-09 | 2021-06-08 | Abbott Laboratories Gmbh | Pharmaceutical composition containing a peptide. |
US11590122B2 (en) | 2021-02-19 | 2023-02-28 | Slayback Pharma Llc | Pharmaceutical compositions of cabozantinib |
CN113512091B (en) * | 2021-05-08 | 2023-06-27 | 漳州未名博欣生物医药有限公司 | Method for synthesizing procalcitonin |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2010065751A2 (en) * | 2008-12-03 | 2010-06-10 | Synergy Pharmaceuticals, Inc. | Formulations of guanylate cyclase c agonists and methods of use |
WO2011020054A1 (en) * | 2009-08-13 | 2011-02-17 | Ironwood Pharmaceuticals Inc. | Method for modulating the pharmacodynamic effect of orally administered guanylate cyclase receptor agonists |
WO2012037380A2 (en) * | 2010-09-15 | 2012-03-22 | Synergy Pharmaceuticals Inc. | Formulations of guanylate cyclase c agonists and methods of use |
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PT3708179T (en) | 2024-01-09 |
HK1204454A1 (en) | 2015-11-20 |
US20120237593A1 (en) | 2012-09-20 |
CA2867292A1 (en) | 2013-09-19 |
JP2015511961A (en) | 2015-04-23 |
EA201491697A1 (en) | 2015-02-27 |
EP2825188A1 (en) | 2015-01-21 |
EP2825188B1 (en) | 2020-03-04 |
EP4309673A2 (en) | 2024-01-24 |
EP3708179A1 (en) | 2020-09-16 |
PL3708179T3 (en) | 2024-04-22 |
AU2013232306B2 (en) | 2017-11-16 |
ES2797628T3 (en) | 2020-12-03 |
JP2019112452A (en) | 2019-07-11 |
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